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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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The purpose of this study is to: 1.) Evaluate how your body reacts to sorafenib when taken daily (continuously) in combination with docetaxel given every 3 weeks, and to determine the safety of the two drugs together.2.) Measure your blood levels of sorafenib and docetaxel at specific times after taking the medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Drug | Sorafenib 400mg by mouth daily in combination with docetaxel 60mg/m2 IV once every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety, maximum tolerated dose and dose-limiting toxicities of oral sorafenib | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To determine if there is a pharmacokinetic interaction between sorafenib and docetaxel when they are administered together | 6 weeks |
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Inclusion Criteria:
Age greater than or equal to 18 years
Advanced histological or cytological documentation of cancer
At least one evaluable lesion
ECOG Performance Status of 0 or 1
No more than one prior chemotherapy regimen (prior adjuvant therapy, immunotherapy or hormone treatment are allowed and not restricted)
Life expectancy of at least 12 weeks
No previous exposure to docetaxel or sorafenib
Adequate bone marrow, liver and renal function as assessed by the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampa | Florida | 33612 | United States | |||
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Philadelphia |
| Pennsylvania |
| 19111-2497 |
| United States |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |